CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse recalled
Young Dental Manufacturing I is recalling Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse, distributed nationwide in the US. The recall was initiated on 13 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2143-2024
- FDA event ID
- 94756
- Recalling firm
- Young Dental Manufacturing I, Earth City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2024
- FDA classified
- 13 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 13 May 2024 | Recall initiated by company | |
| 13 Jun 2024 | Classified by FDA | +31 days |
| 19 Jun 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Product as listed by the FDA
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Where it was distributed
US Nationwide distribution in the state of TN.
Questions about this recall
Why was it recalled?
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Which lots are affected?
Unique Device Identifier (UDI)1: 00889813036273; Lot: 248607; Part number 040032 is the Young Dental part number. The Darby Dental Part Number (that is on the label) is 9518637.
Where was it sold?
US Nationwide distribution in the state of TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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